The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty
Primary Purpose
Hip Arthropathy, Fasting, Patient Comfort
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
oral carbohydrate solution
Sponsored by
About this trial
This is an interventional supportive care trial for Hip Arthropathy focused on measuring oral carbohydrate solution, anxiety, comfort
Eligibility Criteria
Inclusion Criteria:
- Who volunteered to participate in the research,
- Total hip replacement surgery planned,
- Who are over 18 years old,
- ASA I and II group,
- First time hip replacement surgery
Exclusion Criteria:
- Diabetes mellitus,
- In the emergency patient group,
- with gastroesophageal reflux,
- Those with esophageal disease (Hiatus hernia, esophagitis, achalasia…)
- Having endocrine problem,
- Diagnosed with ileus,
- With pyloric stenosis,
- ASA III and IV group,
- Intravenous fluid administered before surgery,
- Using drugs that affect blood glucose levels,
- Previous hip replacement surgery
- Body mass index over 35kg/m2 (The value obtained by dividing the weight in kilograms by the square of the height in meters),
- Having a psychiatric and neurological diagnosis, poor general condition,
- Needing all kinds of fluid and blood support in the pre-operative period,
- Patients who use alcohol or cigarettes
Sites / Locations
- Gülden Küçükakça Çelik
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
oral carbohydrate solution
control
Arm Description
Oral carbohydrate solution was given orally to the experimental group as 800 ml at 24:00 the night before the surgery and 400 ml at 06:00 2 hours before the intervention.
From 24:00 on the night before the surgical intervention, food and water intake was prohibited for the patients in the control group.
Outcomes
Primary Outcome Measures
preoperative anxiety
State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the highest score is 80. High scores indicate high anxiety levels, low scores indicate low anxiety levels.
preoperative anxiety
State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the highest score is 80. High scores indicate high anxiety levels, low scores indicate low
patient comfort
Post Hip Replacement Comfort Scale (The highest average score obtained from the scale is 5 and the lowest average score is 1. A high score indicates high comfort, and a low mean score indicates low comfort.)
Secondary Outcome Measures
postoperative anxiety
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
postoperative pain
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
postoperative sensation of thirst
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
postoperative nausea- vomiting
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
postoperative sensation of hunger
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
physiological parameter
pulse rate/minute
physiological parameter
pulse rate/minute
physiological parameter
pulse rate/minute
physiological parameter
respiratory rate/minute
physiological parameter
respiratory rate/minute
physiological parameter
respiratory rate/minute
physiological parameter
blood pressure (systolic and diastolic mmHg)
physiological parameter
blood pressure (systolic and diastolic mmHg)
physiological parameter
blood pressure (systolic and diastolic mmHg)
physiological parameter
oxygen saturation (SpO2, %)
physiological parameter
oxygen saturation (SpO2, %)
physiological parameter
oxygen saturation (SpO2, %)
physiological parameter
heat (Centigrade degree)
physiological parameter
heat (Centigrade degree)
physiological parameter
heat (Centigrade degree)
physiological parameter
blood glucose (mg/dL)
physiological parameter
blood glucose (mg/dL)
physiological parameter
blood glucose (mg/dL)
Full Information
NCT ID
NCT05134207
First Posted
October 14, 2021
Last Updated
March 4, 2022
Sponsor
Nevsehir Haci Bektas Veli University
1. Study Identification
Unique Protocol Identification Number
NCT05134207
Brief Title
The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty
Official Title
The Effect of Oral Carbohydrate Solution Given Before Hip Artroplasty on Preoperative Anxiety and Postoperative Patient Comfort
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
August 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nevsehir Haci Bektas Veli University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Surgical interventions are not only a physiological trauma, but also a psychological and social trauma because they cause deterioration of the individual's comfort. Comfort is among the most basic human needs and provides a better care output. One of the conditions that cause deterioration of comfort and anxiety in patients is hunger and thirst before surgery. Since 1994, several guides published by professional groups in many countries on pre-operative fasting periods have published that clear liquids can be taken up to 2 hours before the surgery in elective surgeries, and solid foods can be taken up to 6 hours before the surgery. One of the basic principles of ERAS protocols, which include evidence-based care interventions applied at all stages of the surgical process, for the preoperative period is to ensure that the patient takes a carbohydrate drink up to two hours before anesthesia and to shorten the long fasting period. In many countries, the problems experienced by patients as a result of long-term hunger have been identified. When the comfort status of the patients who were given carbohydrate-rich drinks before the surgery was examined, it was observed that the symptoms such as thirst, hunger, insufficiency, fatigue, nausea, pain, anxiety and depression were reduced and oral carbohydrate solutions were recommended. In the literature, it is stated that the prolongation of the fasting period causes an increase in the anxiety of the person and negatively affects his comfort, and it is recommended to drink 800 ml of carbohydrate liquid food until midnight the day before the surgery and 400 ml of liquid carbohydrate food 2-3 hours before the surgery in order to provide metabolic satiety. The nurse, who is one of the health workers responsible for the care of the patient, has to manage the restriction of oral food and liquid intake and the comfort of the patient in the best way before the operation. Accordingly, in our study, the answers were sought whether the oral carbohydrate solution given before hip arthroplasty had an effect on anxiety and patient comfort.
Detailed Description
Hip arthroplasty (HA) is a very common treatment method in orthopedic surgery worldwide. HA is considered a successful, safe and cost-effective medical intervention to regain pain-free mobility and functionality of the hip joint in patients with severe joint disease or trauma.
It is stated that the annual number of patients undergoing HA in the United States is 193,000, and this number is approximately one million worldwide. In the next 15 years, it is estimated that the number of patients undergoing HA will continue to increase in the world and in Turkey.
It is stated that health care services should start in the preoperative period and continue in the postoperative period, especially in HA surgeries performed due to limitation of mobility. Because HA application is seen as a major surgical intervention and as with many surgical interventions, it can affect the individual as a whole.
Surgical intervention is a combination of anesthesia, drug therapy, tissue trauma, blood loss and body temperature changes. These developing events stimulate metabolic changes and cause postoperative anxiety and stress response at the same time. Exposure of the human body to surgery or other trauma elicits a neurohumoral response and activates a catabolic process. Surgical stress causes an increase in the release of regulatory hormones such as catecholamine, glucagon and cortisol in the body and a decrease in insulin sensitivity. The increase in cortisol level leads to the development of insulin resistance and hyperglycemia, which have an important effect on the healing process. Changes in this process increase the risk of postoperative complications and mortality.
On the other hand, fasting the patient overnight as a standard practice in the preoperative period in order to reduce the risk of lung aspiration in elective surgery patients may cause a change in the insulin glucagon ratio. This increases the stress response to surgical trauma and may have a major impact on glycemic control and insulin resistance. Prolongation of the preoperative fasting period may cause negative effects such as feeling of hunger, anxiety, restlessness, headache, dehydration, hypovolemia and hypoglycemia. However, the increase in the preoperative fasting period causes a decrease in patient satisfaction, and causes undesirable conditions such as nausea and vomiting in the postoperative period, delaying the healing process and prolonging the hospital stay of the patients.
In the guidelines published in countries such as America, Canada and Europe, it is reported that the longer the fasting period, the negative effects on patient safety and comfort. In elective surgeries, it is recommended that clear liquids can be consumed up to the last two hours and solid foods up to six hours before the surgical procedure in order to reduce anxiety, reduce the negative effects of the stress response on the patient, and ensure patient comfort. In the guideline published by the Turkish Society of Anesthesiology and Reanimation (TARD) in 2005, it is recommended to comply with these criteria in patients who will undergo elective surgery. Therefore, modern perioperative care aims at maximizing the shortening of the fasting period before an elective surgery.
According to Enhanced Recovery After Surgery (ERAS) protocols, one of the elements of modern perioperative care is the administration of preoperative oral carbohydrate loading (OCS). In the literature; oral carbohydrate solution administration before elective surgery; It is stated that it is absorbed from the stomach of the patient in an average of 90 minutes, reduces protein catabolism in the muscles, increases glycogen storage in the liver and reduces insulin resistance. In addition, in other studies conducted in abdominal, orthopedic and cardiac surgery; It has been determined that OCS reduces postoperative metabolic stress, preserves lean body mass and muscle strength, and increases patient comfort by reducing the length of hospital stay.
The concept of patient comfort is defined as the comfort that facilitates daily life. In providing the health care needs, which are extremely stressful for the patient, nurses apply nursing interventions for comfort, which is a concept unique to the individual, allowing the patient to experience less anxiety, be more peaceful and overcome their problems.
Discomforts experienced by the patient during the operation or procedures (pain, nausea, vomiting, hypothermia, anxiety, etc.) may increase the patient's anxiety and may be the main reason for the decrease in comfort. The nurse should provide all necessary nursing interventions to reduce or eliminate the situations that will cause anxiety in the patient before and after each procedure to be applied to the patient. With all these practices, patients can receive a quality nursing care, contribute to their faster recovery and increase their quality of life.
Quality patient care in surgical nursing; should be shaped within the framework of ethical principles such as not harming and providing benefit. In the literature; Evidence for the duration of fasting in the preoperative period is reflected in clinical practice, emphasizing the need to prevent patients from being harmed without putting them at risk. Thus, by managing the hunger period within the scope of evidence-based practices; It is stated that many therapeutic benefits can be obtained, such as reducing anxiety, discomfort, headache, thirst and hunger in the preoperative period, and providing patient comfort by reducing nausea, vomiting and dehydration in the postoperative period.
Managing food and fluid restriction in line with the guidelines in the preoperative period is one of the important responsibilities of the surgical nurse. Thus, the comfort of the patients will be increased, their anxiety will be reduced, and they will be able to return to their normal lives as soon as possible. Working from here; It was aimed to determine the effect of preoperative OCS on anxiety and patient comfort in patients undergoing HA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy, Fasting, Patient Comfort
Keywords
oral carbohydrate solution, anxiety, comfort
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral carbohydrate solution
Arm Type
Experimental
Arm Description
Oral carbohydrate solution was given orally to the experimental group as 800 ml at 24:00 the night before the surgery and 400 ml at 06:00 2 hours before the intervention.
Arm Title
control
Arm Type
No Intervention
Arm Description
From 24:00 on the night before the surgical intervention, food and water intake was prohibited for the patients in the control group.
Intervention Type
Dietary Supplement
Intervention Name(s)
oral carbohydrate solution
Intervention Description
Patients in the intervention group; Preop oral carbohydrate solution was ingested orally twice within 10 minutes, as 800 ml at 24:00 the night before the surgery and 400 ml at 06:00 2 hours before the surgery.
Primary Outcome Measure Information:
Title
preoperative anxiety
Description
State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the highest score is 80. High scores indicate high anxiety levels, low scores indicate low anxiety levels.
Time Frame
10:00 pm the night before surgery
Title
preoperative anxiety
Description
State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the State-Trait Anxiety Scale (The lowest score to be taken from the scale is 20, and the highest score is 80. High scores indicate high anxiety levels, low scores indicate low
Time Frame
just before the patient is sent for surgery
Title
patient comfort
Description
Post Hip Replacement Comfort Scale (The highest average score obtained from the scale is 5 and the lowest average score is 1. A high score indicates high comfort, and a low mean score indicates low comfort.)
Time Frame
Considering that the discharge days of the patients would be different, it was applied on the second day after the operation.
Secondary Outcome Measure Information:
Title
postoperative anxiety
Description
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Time Frame
Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively.
Title
postoperative pain
Description
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Time Frame
Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
Title
postoperative sensation of thirst
Description
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Time Frame
Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
Title
postoperative nausea- vomiting
Description
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Time Frame
Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
Title
postoperative sensation of hunger
Description
Visual analog scale (Values range from 0 to 10 points, and higher values indicate increased severity of assessed symptoms.)
Time Frame
Evaluated at 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour postoperatively
Title
physiological parameter
Description
pulse rate/minute
Time Frame
preoperative night at 10 pm
Title
physiological parameter
Description
pulse rate/minute
Time Frame
immediately before going to the operation
Title
physiological parameter
Description
pulse rate/minute
Time Frame
postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour.
Title
physiological parameter
Description
respiratory rate/minute
Time Frame
preoperative night at 10 pm
Title
physiological parameter
Description
respiratory rate/minute
Time Frame
immediately before going to the operation
Title
physiological parameter
Description
respiratory rate/minute
Time Frame
postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
Title
physiological parameter
Description
blood pressure (systolic and diastolic mmHg)
Time Frame
preoperative night at 10 pm
Title
physiological parameter
Description
blood pressure (systolic and diastolic mmHg)
Time Frame
immediately before going to the operation
Title
physiological parameter
Description
blood pressure (systolic and diastolic mmHg)
Time Frame
postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
Title
physiological parameter
Description
oxygen saturation (SpO2, %)
Time Frame
preoperative night at 10 pm
Title
physiological parameter
Description
oxygen saturation (SpO2, %)
Time Frame
immediately before going to the operation
Title
physiological parameter
Description
oxygen saturation (SpO2, %)
Time Frame
postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
Title
physiological parameter
Description
heat (Centigrade degree)
Time Frame
preoperative night at 10 pm
Title
physiological parameter
Description
heat (Centigrade degree)
Time Frame
immediately before going to the operation
Title
physiological parameter
Description
heat (Centigrade degree)
Time Frame
postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
Title
physiological parameter
Description
blood glucose (mg/dL)
Time Frame
preoperative night at 10 pm
Title
physiological parameter
Description
blood glucose (mg/dL)
Time Frame
immediately before going to the operation
Title
physiological parameter
Description
blood glucose (mg/dL)
Time Frame
postoperative 0th-hour, 2th-hour, 4th-hour, 6th-hour, 12th-hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Who volunteered to participate in the research,
Total hip replacement surgery planned,
Who are over 18 years old,
ASA I and II group,
First time hip replacement surgery
Exclusion Criteria:
Diabetes mellitus,
In the emergency patient group,
with gastroesophageal reflux,
Those with esophageal disease (Hiatus hernia, esophagitis, achalasia…)
Having endocrine problem,
Diagnosed with ileus,
With pyloric stenosis,
ASA III and IV group,
Intravenous fluid administered before surgery,
Using drugs that affect blood glucose levels,
Previous hip replacement surgery
Body mass index over 35kg/m2 (The value obtained by dividing the weight in kilograms by the square of the height in meters),
Having a psychiatric and neurological diagnosis, poor general condition,
Needing all kinds of fluid and blood support in the pre-operative period,
Patients who use alcohol or cigarettes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülden Küçükakça Çelik, Phd
Organizational Affiliation
Nevşehir Hacı Bektaş Veli University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gülden Küçükakça Çelik
City
Nevşehir
ZIP/Postal Code
50300
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Abd El-Naby AG, El-Sayed ZM. "Preoperative Fasting Time and Selected Postoperative Outcomes among Patients Undergoing Abdominal Surgeries: Correlation Study", Journal of Health, Medicine and Nursing. 2016; 26:109-119.
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PubMed Identifier
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Imbelloni LE, Pombo IA, Filho GB. [Reduced fasting time improves comfort and satisfaction of elderly patients undergoing anesthesia for hip fracture]. Rev Bras Anestesiol. 2015 Mar-Apr;65(2):117-23. doi: 10.1016/j.bjan.2013.10.017. Epub 2014 Sep 26. Portuguese.
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The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty
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